Clinical Trial: Bone Marrow Derived Adult Stem Cells for Acute Anterior Myocardial Infarction

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Randomised Controlled Clinical Trial of the Use of Autologous Bone Marrow Derived Progenitor Cells to Salvage Myocardium in Patients With Acute Anterior Myocardial Infarction

Brief Summary:

Study hypothesis :

The purpose of this study is to determine whether Intracoronary infusion of autologous bone marrow derived progenitor cells to patients undergoing primary angioplasty for acute anterior myocardial infarction will lead to an improvement in cardiac function greater than that seen by placebo alone.

Aims

  • To demonstrate that it is safe and feasible to deliver autologous bone marrow derived stem cells within hours of the primary angioplasty procedure
  • To demonstrate the effects of autologous bone marrow derived stem cells on cardiac function using cardiac MRI (or cardiac CT), echocardiography and left ventriculography.
  • To demonstrate the effect of autologous bone marrow derived stem cells in addition to standard care leads to improvement in cardiac function compared to patients saline(placebo) and standard care.

Detailed Summary:
Sponsor: Barts & The London NHS Trust

Current Primary Outcome: Longitudinal change in left ventricular function (ejection fraction) [ Time Frame: 1 year ]

Original Primary Outcome: Longitudinal change in left ventricular function (ejection fraction) as measured by cardiac MRI. [ Time Frame: 1 year ]

Current Secondary Outcome:

  • Longitudinal change in left ventricular function (ejection fraction), change in left ventricular end systolic volume, and change in infarct size [ Time Frame: 3 months ]
  • Longitudinal change in left ventricular function as measured by LV angiography [ Time Frame: 6 months ]
  • Longitudinal change in left ventricular function assessed by echocardiography. [ Time Frame: 6 months ]
  • Change in left ventricular end systolic volume and change in infarct size. [ Time Frame: 12 months ]
  • Longitudinal change in left ventricular function assessed by echocardiography. [ Time Frame: 12 months ]
  • MACE [ Time Frame: 12 months ]
  • Quality of life [ Time Frame: 6 and 12 months ]


Original Secondary Outcome:

  • Longitudinal change in left ventricular function (ejection fraction) Reduction of left ventricular end systolic volume, Change in regional wall motion in infarct area and Change in infarct mass as measured by cardiac MRI [ Time Frame: 3 months ]
  • Change in global ejection fraction as measured by LV angiography and improvement of myocardial contractility, assessed by contrast echocardiogram(wall motion score index). [ Time Frame: 6 months ]
  • Major adverse cardiac events (MACE), Death (independent of cause and sudden death), myocardial infarction (Q-wave and Non-Q-wave), coronary revascularization [coronary bypass or PCI). [ Time Frame: 6 months ]
  • Quality of life [ Time Frame: 6 months ]
  • LV function as measured by cardiac MRI [ Time Frame: 12 months ]
  • MACE [ Time Frame: 12 months ]
  • Quality of life [ Time Frame: 12 months ]


Information By: Barts & The London NHS Trust

Dates:
Date Received: October 2, 2008
Date Started: March 2008
Date Completion: March 2018
Last Updated: August 6, 2015
Last Verified: August 2015